MediWound(MDWD) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $4 million, down from $5 million in Q1 2024, primarily due to lower revenue from BARDA funded development services as the NexoBrid development program nears completion [17] - Gross profit for the quarter was $700,000, representing a gross margin of 19%, compared to $600,000 and a gross margin of 12% in the prior year [17] - R&D expenses totaled $2.9 million, up from $1.5 million in Q1 2024, reflecting continued investment in the EscharEx VALUE Phase III trial [17] - SG&A expenses were $3.1 million, compared to $2.9 million in the prior year [17] - Operating loss for the quarter was $5.2 million, compared to $3.7 million in Q1 2024 [17] - Net loss was $700,000 or $0.07 per share, an improvement from a net loss of $9.7 million or $1.05 per share last year [17] - Adjusted EBITDA loss for the quarter was $4 million, compared to $2.9 million in the prior year [17] - Cash, cash equivalents, and deposits as of March 31, 2025, were $38.7 million, down from $43.6 million at year-end 2024 [19] Business Line Data and Key Metrics Changes - The VALUE Phase III study for EscharEx is on track, with recruitment progressing as planned, aiming to enroll 216 patients across approximately 40 sites in the U.S. and Europe [5][6] - NexoBrid's U.S. adoption continues to expand, with a 207% year-over-year increase and a 31% sequential increase in revenue during Q1 2025 [12] - Demand for NexoBrid in Japan and Europe continues to exceed manufacturing capacity, with a new manufacturing facility expected to be operational by year-end 2025 [12][13] Market Data and Key Metrics Changes - The company has secured a €2,500,000 grant from the European Innovation Council Accelerator to support the clinical and regulatory advancement of EscharEx for diabetic foot ulcers [9] - The U.S. government has expressed interest in establishing a domestic backup manufacturing site for NexoBrid, supported by BARDA [15][25] Company Strategy and Development Direction - The company is focused on scaling manufacturing capabilities to support long-term growth, with a new facility progressing on schedule and U.S. expansion plans underway [21] - EscharEx is positioned to become a global leader in enzymatic wound debridement, with strong clinical advantages over competitors [11] - The company is advancing complementary studies to support market access and future commercial success [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical, commercial, and operational priorities, maintaining momentum from 2024 [4] - The company anticipates achieving operational capacity for the new manufacturing facility by the end of 2025, with regulatory inspections expected thereafter [25] - Management remains optimistic about the VALUE Phase III trial and expects interim data by mid-2026 [31] Other Important Information - The company is planning a 45-patient randomized prospective Phase II head-to-head comparison of EscharEx versus collagenase, scheduled to begin in the second half of 2025 [7] - The pediatric Phase III study results for NexoBrid were published, reinforcing its efficacy and safety [13] Q&A Session Summary Question: What is yet to be done for manufacturing scale-up by year-end? - The construction of the new facility is complete, and the company is in the commissioning phase, expecting operational capacity by the end of 2025 [25] Question: When should investors expect movement on U.S. capacity? - The project for a domestic backup manufacturing site is expected to be finished by Q3 this year, with further details to follow [28] Question: How is enrollment progressing for the VLU study? - Recruitment is progressing as planned, with excitement from leading wound care companies and key opinion leaders [31] Question: How is the stockpiling of NexoBrid being planned? - The company prefers to treat patients rather than stockpile, but there is growing interest from governments for stockpiling [37] Question: What is the structure of the EscharEx trial sites? - Approximately 50% of the sites will be in the U.S., with a focus on recruiting the right patients [39] Question: Will the results of the head-to-head study and phase three study come around the same time? - The head-to-head study is expected to finish ahead of the phase three study due to its shorter duration [43] Question: What factors will influence the pricing strategy for EscharEx? - The pricing strategy will consider treatment costs, health economics, and potential savings from faster debridement [51] Question: How should investors think about BARDA and DoD funding? - The company anticipates no material impact on revenue outlook for 2025, with programs back on track [61]